RSA and registries: the quest for phased introduction of new implants.

Biomechanics and Imaging Group, Department of Orthopaedics, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands. Nelissen:
The Journal of Bone and Joint Surgery (Impact Factor: 4.31). 12/2011; 93 Suppl 3:62-5. DOI: 10.2106/JBJS.K.00907
Source: PubMed

ABSTRACT Although the overall survival of knee and hip prostheses at ten years averages 90%, recent problems with several hip and knee prostheses have illustrated that the orthopaedic community, industry, and regulators can still further improve patient safety. Given the early predictive properties of roentgen stereophotogrammetric analysis (RSA) and the meticulous follow-up of national joint registries, these two methods are ideal tools for such a phased clinical introduction. In this paper, we elaborate on the predictive power of RSA within a two-year follow-up after arthroplasty and its relationship to national joint registries. The association between RSA prosthesis-migration data and registry data is evaluated.
The five-year rate of revision of RSA-tested total knee replacements was compared with that of non-RSA-tested total knee replacements. Data were extracted from the published results of the national joint registries of Sweden, Australia, and New Zealand.
There was a 22% to 35% reduction in the number of revisions of RSA-tested total knee replacements as compared with non-RSA-tested total knee replacements in the national joint registries. Assuming that the total cost of total knee arthroplasty is $37,000 in the United States, a 22% to 35% reduction in the number of revisions (currently close to 55,000 annually) could lead to an estimated annual savings of over $400 million to the health-care system.
The phased clinical introduction of new prostheses with two-year RSA results as a qualitative tool could lead to better patient care and could reduce the costs associated with revision total knee arthroplasty. Follow-up in registries is necessary to substantiate these results and to improve post-market surveillance.

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    ABSTRACT: Background Implant migration, bone mineral density (BMD), length of glenohumeral offset (LGHO), and clinical results were compared for the Copeland (Biomet Inc, Warsaw, IN, USA) and the Global C.A.P. (DePuy Int, Warsaw, IN, USA) humeral head resurfacing implants (HHRIs). Methods The study randomly allocated 32 patients (13 women), mean age 63 years (range, 39-82 years), with shoulder osteoarthritis to a Copeland (n = 14) or Global C.A.P. (n = 18) HHRI. Patients were monitored for 2 years with radiostereometry, dual-energy X-ray absorptiometry, Constant Shoulder Score (CSS), and the Western Ontario Osteoarthritis of the Shoulder Index (WOOS). LGHO was measured preoperatively and 6 months postoperatively. Results At 2 years, total translation (TT) was 0.48 mm (standard deviation [SD], 0.21 mm) for the Copeland and 0.82 mm (SD, 0.46 mm) for the Global C.A.P. (P = .06). Five HHRI were revised, and in the interval before the last follow-up (revision or 2 years), TT of 0.58 mm (SD, 0.61 mm) for revised HHRI was higher (P = .02) than TT of 0.22 mm (SD, 0.17 mm) in nonrevised HHRI. A comparison of TT at the last follow-up (revision or 2 years) found no difference between the HHRIs (P = .12). Periprosthetic BMD decreased initially but increased continuously after 6 months for both HHRIs. At 2 years, BMD was 48% higher around the Copeland HHRI (P = .005). The mean difference in LGHO was significantly higher for the Copeland than for the Global C.A.P. HHRI (P = .02). Clinical results evaluated with CSS and WOOS improved over time for both implant groups (P < .01), with no differences between the groups. Conclusion Both implants had only little migration and good clinical results. Periprosthetic BMD and LGHO both increased for the Copeland HHRI more than for the Global C.A.P HHRI.
    Journal of Shoulder and Elbow Surgery 10/2014; 23(10):1427–1436. DOI:10.1016/j.jse.2014.05.012 · 2.37 Impact Factor
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    ABSTRACT: To determine the evidence of effectiveness and safety for introduction of five recent and ostensibly high value implantable devices in major joint replacement to illustrate the need for change and inform guidance on evidence based introduction of new implants into healthcare.
    BMJ Clinical Research 09/2014; 349:g5133. DOI:10.1136/bmj.g5133 · 14.09 Impact Factor
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    ABSTRACT: Background and purpose - To retain or to sacrifice the posterior cruciate ligament (PCL) in total knee arthroplasty (TKA) remains a matter of discussion. In this systematic review, we wanted to find differences in functional and clinical outcome between the 2 methods. Methods - We conducted a systematic review and meta-analysis including all randomized controlled trials (RCTs) and quasi-RCTs that have compared PCL retention with PCL sacrifice in TKA with a minimum of 1-year follow-up. Primary outcome was range of motion. Secondary outcomes were knee pain and clinical scoring systems that were preferably validated. Quality of evidence was graded using the GRADE approach. All outcomes available for data pooling were used for meta-analysis. Results - 20 studies involving 1,877 patients and 2,347 knees were included. In meta-analysis, the postoperative flexion angle had a mean difference of 2 degrees (95% CI: 0.23-4.0; p = 0.03) and the KSS functional score was 2.4 points higher in favor of PCL sacrifice (95% CI: 0.41-4.3; p = 0.02). There were no statistically significant differences regarding other measured clinical outcomes such as WOMAC, KSS pain, clinical and overall score, HSS score, SF-12, radiolucencies, femoro-tibial angle, and tibial slope. The quality of the studies varied considerably. Risk of bias in most studies was unclear; 5 were judged to have a low risk of bias and 5 to have a high risk of bias. Interpretation - We found no clinically relevant differences between retention and sacrifice of the PCL in TKA, in terms of functional and clinical outcomes. The quality of the studies ranged from moderate to low. Based on the current evidence, no recommendation can be made as to whether to retain or to sacrifice the PCL.